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After a successful legislative operation to remove roadblocks to new drugs and devices,
lawmakers behind the 21st Century Cures law will continue to conduct regular checkups.

“We’re going to make sure the money is well spent,” Rep. Fred Upton (R-Mich.) told
Bloomberg Law, adding that programmatic oversight of the
law will continue as well. “Where we need to come in to fix it, you’ll see us do it.”

Cures, which often is considered Upton’s legacy project, became law shortly before
his chairmanship on the House Energy and Commerce Committee expired at the end of
2016. Upton and his Cures co-pilot Rep. Diana DeGette (D-Colo.)
sat down with Bloomberg Law to discuss how the law is being carried out one year later. They also reflected on
bipartisanship and discussed future plans.

Doctors currently have treatment options for about 500 of the 10,000 known diseases,
according to the Energy and Commerce Committee. The enactment of 21st Century Cures
(
Pub. L. 114-255) on Dec. 13, 2016, culminated a multiyear effort by lawmakers to treat more diseases
and help more patients.

“Our intention in drafting this bill was really to revolutionize the way we do biomedical
research at the National Institutes of Health and then device and drug approval at
the FDA,” DeGette said. “We have 350 pages of real changes in the way we do patient
studies and the way we do data and the way we expedite drug and device approvals—all
of that.”

New FDA Authorities

For the
Food and Drug Administration, the law gives the agency authorities to expedite breakthrough devices and regenerative
medicine products as well as streamline approvals of cancer treatments through a new
Oncology Center of Excellence. It also aims to give the agency the tools to hire the experts it needs to review
emerging technologies such as genomics. The FDA currently has more than 1,200 vacancies
in its official record system, an agency spokeswoman told Bloomberg Law Dec. 12.

For the
NIH, Cures aims to remove administrative roadblocks so investigators can spend more time
on their research and less time on paperwork. It also provides $4.8 billion over 10
years to fund four areas: precision medicine; the cancer moonshot to double the rate
of progress on oncology treatments and prevention therapies; regenerative medicine;
and brain research.

These are some of the fields where, DeGette said, the law may need tweaking. “Because
the research is evolving at such a mind-blowing rate, then the legislation’s going
to have to evolve, too.”

Young Investigators

There are also initiatives to help young researchers establish their careers and keep
them from dropping out of the workforce. The
average age of an investigator with an independent grant has pushed up into the early 40s, raising
concern that younger scientists will drop out of the biomedical research workforce
and there won’t be enough scientists to harness the emerging technologies that are
coming down the pike. NIH Director Francis S. Collins said from his first day taking
over the agency in 2009 this is a concern that keeps him up at night.

While faster discovery and development of novel treatments kicked off the legislative
project several years ago, the final Cures law was a broad-based health package that
also addressed opioid abuse, mental health-care reform, and health information technology.

Opioid Funds

Members of the Energy and Commerce Committee, which includes Upton, will work with
House appropriators on renewing state grants authorized under Cures, Upton said. He’s
hoping for a multiyear extension to give state programs room to grow, he said.

The Cures Act called for $1 billion in state grants set to run out at the end of fiscal
2018, so lawmakers are eyeing new funds to keep state drug treatment and addiction
prevention programs running, Upton said. Lawmakers are also looking for funds to expand
postal inspections to stop the flow of drugs via the U.S. Postal Service, he said.

Energy and Commerce Chairman Greg Walden (R-Ore.) plans to hold a series of opioid-related
hearings in early 2018, DeGette noted. “And Fred and I are going to make sure that
opioid funding is a part of that, to give that funding stream for a long period of
time.”

Both lawmakers said they remain optimistic, and DeGette indicated there are other
issues being discussed. “We were really encouraged that we were able to do a big bill
like this in a bipartisan way,” she said. Upton added the Cures process can serve
as an example for future efforts. “This was how Congress ought to function,” he said.

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